Friends Prod Bush on Next FDA Commissioner

A spirited tug of war is unfolding behind the scenes in the Bush administration over who should become the next commissioner of the Food and Drug Administration--a tussle that could force the president to choose between his friends.

Thus far, it is a contest between the pharmaceutical industry--which last year gave $4.4 million to President Bush and the Republican Party--and Bill Frist, the powerful Republican senator from Tennessee who is one of Bush’s most influential supporters on Capitol Hill.

Both are promoting their own candidates, and whomever the president selects likely will determine the future direction of the FDA, which regulates most foods that Americans eat, the drugs that they take and the cosmetics and medical devices that they use--products that in fact account for 25 cents of every consumer dollar spent.

The $100-billion-a-year pharmaceutical industry is eager to maintain the FDA’s fast-track approach to approving drugs, and it believes that someone coming from its own ranks would have the best grasp of its regulatory needs.

Even better, drug manufacturers think, would be someone with pharmaceutical industry and FDA experience. To that end, they are promoting several candidates with solid FDA credentials who now work for drug manufacturers.

Agency Has Fought to Maintain Balance

The FDA has been struggling to maintain a balance between licensing drugs as speedily as possible and ensuring public safety; in recent years, however, the agency has been forced to remove a record number of medicines from the market because of safety problems.

Frist, the Senate’s only licensed physician, is supporting Dr. Raymond Woosley--an associate dean at Georgetown University Medical Center, a doctor and a pharmacologist. He is known to believe that there should be a better system for tracking safety problems of FDA-approved drugs--a stance that makes the industry nervous.

“It looks like Bush will have to choose between friends,” said one former high-ranking FDA official who requested anonymity. “And during the political jockeying, you’ll see people reading all sorts of motivations and positions [into] each of the candidates--and not all of them will be accurate.”

Woosley has been actively involved in studying the issue of drug safety--in particular, cases in which patients suffer unexpectedly dangerous reactions to drugs that have been correctly prescribed.

Drug industry officials argue that they are not looking for a puppet--just someone who understands their needs, as well as those of consumers.

Among their favored candidates are Dr. Michael Friedman and Dr. Bruce Burlington, both of whom held high-level FDA positions before joining the ranks of industry. Another name mentioned is Dr. Ed Scolnick, president of Merck Research Laboratories.

Friedman was the FDA’s deputy commissioner for operations and served as acting commissioner after Dr. David Kessler left to become dean of Yale University’s medical school in 1997. He reportedly wanted the top job then, but he left when Dr. Jane E. Henney--former President Clinton’s last FDA commissioner--was tapped. An internist and cancer specialist, Friedman now is vice president for research and development at Searle, a division of Pharmacia Corp., where he works on drugs for cancer, and heart and metabolic diseases.

Burlington--who is credited with cleaning up the FDA’s generics branch after a bribery scandal in the 1980s and who later ran the agency’s medical devices center--now works at Wyeth-Ayerst Pharmaceuticals, the global pharmaceutical division of American Home Products.

“Those are the people who could do the job who would be fair,” said Mark Grayson, a spokesman for the Pharmaceutical Manufacturers of America, an industry trade group.

And while they are busy jockeying for their own candidates, industry officials also wouldn’t mind if the White House takes its time finding a successor to Henney.

Without a permanent chief, the agency is perceived as weaker, “and industry likes that,” said a former high-ranking FDA official who declined to be identified.

There is every indication the White House will do just that. It could be months before a decision is made--and even longer before someone takes over. And Bush has given no indication of which way he is leaning.

In the meantime, the agency is being run by Dr. Bernard A. Schwetz, a veterinarian and toxicologist who served as Henney’s acting deputy and as director of the agency’s National Center for Toxicological Research. He is not considered to be in the running for the job.

Other candidates include Dr. Lynn A. Drake, head of the department of dermatology at the University of Oklahoma’s Health Sciences Center. In 1991, Drake was appointed by former President Bush to the U.S. delegation to the World Health Assembly; Dr. Robert M. Califf, a cardiologist at Duke University Medical Center; Dr. David Feigal, head of the FDA’s Center for Devices and Radiological Health; and Peter Barton Hutt, a former FDA general counsel who has a private law practice.

Dr. Murray Lumpkin--the former deputy director of the FDA’s Center for Drug Evaluation and Research who now is a senior medical advisor in the commissioner’s office--also has been mentioned for the job. But he has been widely criticized for keeping the controversial diabetes drug Rezulin on the market. It since has been withdrawn.

Firsthand Experience With Woosley

Frist, in his support of Woosley, has drawn upon their collaboration in recent years--as well as when they worked as doctors together years ago at Vanderbilt Medical Center in Tennessee.

“Because we often shared in the care of patients with serious heart disease, I was able to see firsthand why he was respected as a physician and as a scientist,” Frist wrote in a recent letter to Health and Human Services Secretary Tommy G. Thompson. “My impressions were corroborated when practicing physicians elected him as one of the ‘Best Doctors in America.’ ”

Calling Woosley “an outstanding candidate” for FDA commissioner, Frist cited his “real world experience as a researcher, teacher and clinical practitioner” in his letter to Thompson. The FDA is part of HHS.

Woosley in recent years has studied drug safety, particularly how drug reactions differ among individual patient populations, such as by sex or race. As FDA chief, he likely would push for rapid development of drugs--but only if combined with a stronger safety review.

He worked closely with Frist in creating an academic-based research program launched by the Rockville, Md.-based Agency for Healthcare Research and Quality, part of HHS. The program, among other things, studies drug interactions with the aim of reducing dangerous side effects.

“He’s very smart, and has both scientific and research skills, and isn’t afraid to be critical,” said one Georgetown colleague who did not want to be identified.

Drug industry officials refused to comment on Woosley. In fact, most experts interviewed asked not to be quoted by name, fearing they would torpedo their candidates’ prospects or say something about somebody that could come back to haunt them.

Many of those mentioned as possible candidates also refused to comment.

Of the industry candidates, Burlington--who while at the FDA helped speed up the approval time of new medical devices--is regarded as a taskmaster who gets the job done but who sometimes can be difficult to work with.

“There are people both inside and outside the agency who had problems with him, personality-wise,” said one former HHS official. “But he’s clearly somebody who can go in and make things happen. He has the reputation of a can-do guy who takes difficult situations and improves them.”

Friedman, a cancer specialist who worked for many years at the National Cancer Institute, was asked to “keep the FDA steady between commissioners, and he did,” one former agency official said. But as acting head of the agency, the former official said, Friedman was “much more than a caretaker.” He worked with lawmakers in reauthorizing a popular measure that charges drug makers “user fees” that go toward hiring additional drug reviewers, which helps speed up the approval process.

He also was involved in helping lawmakers draft FDA reform legislation--a law now being blamed in part for some of the safety problems with drugs that have been removed from the market.

Some see industry ties as a plus, arguing that the experience can better help regulators understand the drug companies’ needs.

Others are not so sure.

“You can’t have someone who’s been in the industry be the regulator,” Kessler said. “It sends the wrong signal.”